AU/NZ NeeS Compiler - TGA/Medsafe Non-eCTD

AU/NZ NeeS Compiler, a part of eCTD Office, is an authenticated NeeS preparation, creation, manipulation, validation and publishing system for TGA/Medsafe electronic submissions for human medicinal products.

TGA Biologicals

Medsafe NMA

TGA Biologicals Submissions

The Australian Regulatory Guidelines for Biologicals published by the TGA in June 2011 stipulate a specific dossier structure for registration of human cell and tissue-based therapeutic goods (collectively defined as 'biologicals'). Use eCTD Office Templated Compiler to generate the precise dossier structure quickly and easily, save the template and use for all subsequent submissions. A fully bookmarked, hyperlinked Table of Contents is generated when the dossier is published, for ease of navigation and evaluation at the TGA.

Medsafe New Medicine Applications

Customised templates for compilation and publishing of NMAs for evaluation under either the non-abbreviated process or the extended abbreviated process can be generated quickly and easily. Convert TGA, FDA, Health Canada, EMA and MHRA dossiers to the format required by Medsafe with minimal additional manipulation. Save customised templates for future use. All dossiers published using eCTD Office are fully hyperlinked and bookmarked to the Table of Contents that is generated, facilitating navigation and evaluation at Medsafe.